Effects of Physical Exercise, Cognitive Stimulation, and Their Combination on Mobility, Cognitive Function, and Psychosocial Well-Being in Older Adults Residing in Long-Term Care: Protocol for a Randomised Controlled Trial
Nuno Carvalho, Rocío Llamas-Ramos, Inés Llamas-RamosBackground/Objectives: Older adults residing in long-term care frequently experience multimorbidity, low habitual activity, mobility decline, executive dysfunction, and reduced quality of life. Evidence separating the effects of exercise, cognitive stimulation, and their combination remains limited. The primary objective of this trial is to determine whether a 12-week combined physical exercise plus cognitive stimulation programme improves executive function, functional mobility, and health-related quality of life compared with usual care. Secondary objectives are to estimate the effects of each single-component programme, compare the combined programme with each component, and examine maintenance at six months. Methods: This is a four-arm, parallel-group, assessor-blinded randomised controlled trial in Portuguese long-term care facilities. A total of 140 residents aged 65 years or older, residing in long-term care for at least three months and able to provide informed consent, will be allocated 1:1:1:1 to supervised multicomponent exercise, group cognitive stimulation, combined exercise plus cognitive stimulation, or usual care. Active programmes will be delivered three times weekly for 12 weeks. Assessments are planned at baseline, post-intervention, and six-month follow-up according to the prespecified schedule. Primary outcomes are the Stroop interference score, Timed Up and Go time, and EQ-5D-5L index value at 12 weeks. Analyses will follow the intention-to-treat principle using mixed-effects models; multiplicity across the three primary endpoints will be controlled using Holm’s procedure, and interaction analyses will be exploratory and hypothesis-generating. Results: Recruitment and data collection had not started at manuscript submission; therefore, no participant data are reported. Conclusions: The trial will estimate the effects of the combined programme versus usual care and provide exploratory comparative evidence on the single-component programmes in real-world long-term care.